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A Study of BMS-863233 in Patients With Hematologic Cancer

This study has been terminated.
Sponsor:
Collaborator:
Exelixis
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00838890
First received: February 6, 2009
Last updated: January 24, 2011
Last verified: October 2010
  Purpose

To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer


Condition Intervention Phase
Refractory Hematologic Cancer
Drug: Cdc7-inhibitor (BMS-863233)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until maximum tolerated dose is reached ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until the MTD is reached ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until the MTD is reached ] [ Designated as safety issue: No ]
  • To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until the MTD is reached ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cdc7-inhibitor (A) Drug: Cdc7-inhibitor (BMS-863233)
Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months
Other Name: BMS-863233
Active Comparator: Cdc7-inhibitor (B) Drug: Cdc7-inhibitor (BMS-863233)
Tablets, Oral, MTD of Cdc7-inhibitor (A) Arm, QD x 7 days until MTD achieved, 7 days per 21 day cycle/QD, 12 months
Other Name: BMS-863233

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AML by current WHO diagnostic criteria, any FAB type (except APML), Refractory ALL, Accelerated/blast phase CML and Refractory MDS with total IPSS score of 2 or higher
  • ECOG performance status <= 2
  • Accessible for treatment, PK sample collection and required study follow-up
  • Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 3 x ULN

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Subjects with Acute Promyelocytic leukemia disease or CNS leukemia disease)
  • Hyperleukocytosis (defined as peripheral WBC >50,000/uL)
  • Treatment with any other investigational agent for any indication within 30 days of protocol enrollment
  • Subjects a history of gastrointestinal disease
  • Subjects less than four weeks from allogenic or autologous stem cell transplant infusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838890

Locations
United States, Florida
University Of Miami
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Roswell Park
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Bristol-Myers Squibb
Exelixis
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00838890     History of Changes
Other Study ID Numbers: CA198-001
Study First Received: February 6, 2009
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hematologic Neoplasms
Hematologic Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 24, 2014